Strategic Regulatory Affairs under the MDR
With AI-enabled Regulatory Intelligence for better monitoring and decision-making
- Excellent speakers
- Practical transfer through case studies
- AI tools in regulatory affairs
- Officially certificated ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes high-quality course material and a participation certificate for download, access to the Learning Space as well as technical support including a test meeting.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes high-quality course material and a participation certificate for download, access to the Learning Space as well as technical support including a test meeting.
Regulatory strategy under the MDR calls for well-structured authority interactions, efficient internal processes, and the ability to identify and assess regulatory developments at an early stage. This seminar shows how to strengthen strategic Regulatory Affairs in practice, including the targeted use of AI-enabled Regulatory Intelligence for monitoring, analysis, and risk assessment.
Your speakers
Jürgen Mehring
Mehring Consulting, Ahlen, GERMANY
Lead Auditor ISO 13485 and ISO 27001; independent consultant specialising in quality management, regulatory affairs, information security, and integrated management…
Your speaker
Jürgen Mehring
Mehring Consulting, Ahlen, GERMANY
Lead Auditor ISO 13485 and ISO 27001; independent consultant specialising in quality management, regulatory affairs, information security, and integrated management systems
Jürgen Mehring brings 26 years of experience in medical technology, including 16 years as an independent consultant. He supports medical technology companies in regulatory affairs, quality management, information security, technical documentation, audits, electronic quality management systems (eQMS), and integrated management systems. His objective is to enable organisations to implement regulatory, organisational, and quality-related requirements in a structured, standards-compliant manner through pragmatic solutions, efficient processes, and future-ready approaches - including the strategic deployment of AI tools.
Michael Renaudin
veanu GmbH, Bern, SUISSE
Managing director
Michael Renaudin is Chief Executive Officer of veanu GmbH, a Bern-based company specialising in digital transformation within regulated organisations. He…
Your speaker
Michael Renaudin
veanu GmbH, Bern, SUISSE
Managing director
Michael Renaudin is Chief Executive Officer of veanu GmbH, a Bern-based company specialising in digital transformation within regulated organisations. He studied social anthropology and sociology at the University of Bern and completed postgraduate education in human resources, digital leadership, and executive management. He spent fifteen years at Swissmedic, Switzerland's pharmaceutical authority, initially leading organisational learning and talent development, then heading Swissmedic 4.0—the agency's innovation lab—where he directed its digital transformation initiatives. His background encompasses information technology, project management, and adult education. He teaches and publishes on leadership and knowledge management, with particular focus on how regulatory authorities can harness data, knowledge, and artificial intelligence to modernise their operations. He became Chief Executive Officer of veanu GmbH in October 2025.
Dr. iur. Arkan Zwick
CROMA PHARMA GmbH, Leobendorf, AUSTRIA
Regulatory Affairs Director;
Arkan Zwick, PhD iur., is Head of the Regulatory Affairs Department at CROMA PHARMA GmbH. He is responsible for the global regulatory…
Your speaker
Dr. iur. Arkan Zwick
CROMA PHARMA GmbH, Leobendorf, AUSTRIA
Regulatory Affairs Director;
Arkan Zwick, PhD iur., is Head of the Regulatory Affairs Department at CROMA PHARMA GmbH. He is responsible for the global regulatory compliance of the company and for market approvals in the EU, North America, LATAM and Asia-Pacific. He holds a doctorate in law and has been working in the legal and regulatory area of medical devices and pharmaceutical products for many years.
What to Expect
- Strategic approaches and practical tools for Regulatory Affairs under the MDR
- Effective interaction with notified bodies and authorities
- Internal process organisation and integrated management systems
- AI, NLP, and large language models in Regulatory Affairs
- Risk, scenario, and KPI-based approaches to managing regulatory processes
Who Should Attend
This seminar is designed for specialists and managers in Regulatory Affairs and quality management within the medical devices industry who want to strengthen their regulatory strategy and make targeted use of AI-enabled tools in their day-to-day work.
Participants should have a good working knowledge of the MDR and practical professional experience in a regulatory environment.
Objective of the Event
The seminar provides methods and practical tools for planning and managing regulatory processes for medical devices under the MDR. It focuses on structured dialogue with notified bodies and authorities, integrated management systems as the basis for effective regulatory operations, and AI-enabled Regulatory Intelligence for the early identification and assessment of regulatory developments. The programme is rounded off by practical case studies, risk and scenario analyses, and KPI-based management approaches.
Your Benefit
- Strengthen your regulatory strategy under the MDR
- Improve communication with notified bodies and authorities
- Identify relevant regulatory developments earlier and assess them more systematically
- Use AI-enabled tools for Regulatory Intelligence in a focused and practical way
- Transfer case study insights directly into your own regulatory processes
Programme
09:00 - 17:00 CET
09:00
09:15
Dr Arkan Zwick
- Strategic requirements under the MDR
- Strategic approaches in Regulatory Affairs
- Instruments of regulatory strategy
09:45
Dr Arkan Zwick
- Briefing books and structured dialogue
- Dos and don'ts when dealing with notified bodies and authorities
11:00
11:15
Dr Arkan Zwick
12:15
13:15
Jürgen Mehring
- Embedding Regulatory Intelligence effectively within the organisation
- AI- and NLP-supported preparation of regulatory information for internal processes
14:00
Jürgen Mehring
- Management systems as the structural basis for regulatory processes
- Interfaces between Regulatory Affairs, quality management, and information security
14:30
14:45
Michael Renaudin
- AI-based platforms for global regulatory monitoring
- NLP and large language models for the analysis of regulatory texts
- Practical example: integration into approval and market access workflows
16:15
Jürgen Mehring
- Identifying early warning signals systematically
- Assessing regulatory risks in a structured way
- Managing regulatory processes on the basis of KPIs
17:00
Welcome and introduction
09:15
Fundamentals of strategic action
Fundamentals of strategic action
Dr Arkan Zwick
- Strategic requirements under the MDR
- Strategic approaches in Regulatory Affairs
- Instruments of regulatory strategy
09:45
Interaction with authorities
Interaction with authorities
Dr Arkan Zwick
- Briefing books and structured dialogue
- Dos and don'ts when dealing with notified bodies and authorities
Coffee break
Case studies: addressing regulatory gaps and modular reviews
Lunch break
13:15
Communication strategies within the organisation
Communication strategies within the organisation
Jürgen Mehring
- Embedding Regulatory Intelligence effectively within the organisation
- AI- and NLP-supported preparation of regulatory information for internal processes
14:00
Integrated management systems in Regulatory Affairs
Integrated management systems in Regulatory Affairs
Jürgen Mehring
- Management systems as the structural basis for regulatory processes
- Interfaces between Regulatory Affairs, quality management, and information security
Coffee break
14:45
Regulatory Intelligence: AI-enabled tools for monitoring and analysis
Regulatory Intelligence: AI-enabled tools for monitoring and analysis
Michael Renaudin
- AI-based platforms for global regulatory monitoring
- NLP and large language models for the analysis of regulatory texts
- Practical example: integration into approval and market access workflows
16:15
Risk, scenario analysis and KPI-based management
Risk, scenario analysis and KPI-based management
Jürgen Mehring
- Identifying early warning signals systematically
- Assessing regulatory risks in a structured way
- Managing regulatory processes on the basis of KPIs
End of seminar
Downloads
Request the documents using our form.
Abbreviation List: Medical Devices
Further Informations
In-house trainings
Would you like to train several employees from your company or department on a specific topic in the field of Regulatory Affairs in a cost-efficient way? If so, we are the right partner for you.
Whether you would like to implement an existing seminar concept as an inhouse training course or require a new training programme tailored to the specific needs of your team, we would be pleased to support you.
You can choose between:
- online or on-site at your premises
- in German or English
- for 5 or 50 participants
We would be pleased to plan and organise your inhouse training course. Please feel free to contact us by phone or email. We look forward to supporting you with your training needs.
Verena Planitz
Conference Manager Pharma / Healthcare
v.planitz@forum-institut.de
Phone: +49 6221 500-655
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
Our Recommendations
Further Information
e-Learning - Click and learn
We provide flexible education and training with high-quality e-Learning programmes for several topics.
List of abbreviations pharma & healthcare
Many abbreviations are used in pharma & healthcare. Download the list of the most important ones.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de